Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain

NCT00153192 | Completed Phase 2

• 2 other identifiers: 2001-P-000474BN7894973
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if Marinol alleviates pain in patients with chronic pain who are currently taking opioids. The study begins with a 2-hour initial visit followed by three 8-hour appointments at Brigham and Women's Hospital. At each 8-hour visit, patients receive a dose of medication and complete surveys relating to pain. During the first visit a brief examination and a few surveys about pain, quality of life, and medical history are given. The study doctor then determines if the participant continues to qualify for the study. If qualified for the study, patients receive a daily diary to record pain levels and pain medications; this will take about 5 minutes each day. After completion of the diary, patients begin the 8-hour visits. Patients visit the Pain Trials Center three times to receive study medication. After taking the study medication, participants remain in the clinic for 8 hours to complete hourly surveys about pain and pain relief. Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at home, and pain levels are recorded in a diary. Participants can change the dose of study drug to better control pain and side effects, after speaking with study staff. The study then concludes with a final 30-minute visit to summarize the participant's experience in the clinical trial.

Conditions

Chronic Pain

Keywords

Marinol; Dronabinol; Cannabinoid; Chronic Pain

Outcome Measures

Primary Outcomes (4)

• Single-Dose Phase

• - Total pain relief (TOTPAR) at 8 hours

• Multi-Dose Phase

• - Change in pain score from baseline

Secondary Outcomes (19)

• Single-Dose Phase

• - Sum of pain intensity differences at 8 hours

• - Pain and pain relief at all prespecified time points

• - SPID for pain bothersomeness at 8 hours

• - Side effects scale

Interventions

Marinol (dronabinol) DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic somatic nociceptive pain syndromes\*, with a minimum pain score on average of 4/10
• Stable doses of opioid analgesics per investigator judgment
• Negative urine pregnancy test in all females with reproductive capacity
• Patients agree to use adequate birth control measures during the study
• (\*including but not limited to, musculoskeletal pain, neck pain, low back pain, pain due to osteoarthritis, fibromyalgia, failed back surgery syndrome etc.)

You may not qualify if:

• Current substance abuse by self-report.
• Chronic pain due to cancer
• Any marijuana use within three months by self-report
• Active litigation, compensation, or disability issues
• Significant baseline nausea, vomiting, sedation, or other symptoms that may compromise the collection of study-related data
• Patients on a baseline opioid regimen that requires opioid dosing more frequently than every 8 hours
• Unstable psychiatric disorders per investigator judgment
• Baseline Beck depression inventory indicating moderate or greater depression, or active suicidality
• Baseline anxiety inventory indicating moderate or greater anxiety
• Patient feels unable to defer morning opioid dose until arrival in the study center
• Patients using Duragesic patch
• Patients receiving opioids via an implanted intrathecal pump

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Sanjeet Narang, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Anesthesia, Harvard Medical School

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2001
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: April 26, 2013

Record last verified: 2013-04

Locations

US (1)